QA Associate (Shift)

  • Contract
  • Cork

Website Ref:TPM04558

Summary:
A QA Associate is required for a biopharmaceutical company in Cork.

Responsibilities:

  • Provide QA support to the site for drug substance GMP operations (Warehouse/material operations, Upstream/Downstream and Support Services manufacturing, Automation and Process Engineering, MES, QA Validation and Capital Projects).
  • Participate within inter-departmental and cross-functional teams to immediately address issues in real time.
  • Exercise judgment to determine appropriate action, ensuring proper escalation when issues are identified as per applicable procedures for compliance, escalation and corrections.
  • Review of MES Exceptions.
  • Support lot release activities/schedule including preparation of BDS/FBDS lot files.
  • Daily presence and support in the process teams and on the manufacturing floor including walk-through of process issues and RCAR support.
  • Release of Raw Materials for drug substance production.
  • Review and approve deviations and QC LIR reports to ensure that root causes have been identified, appropriate corrective actions have been implemented and appropriate impact assessments are complete.
  • Review and approve Change Control documents pertaining to Warehouse/material operations,
  • Upstream/Downstream and Support Services manufacturing, QC In process/Micro, Automation and Process Engineering, QA Validation, IT/CSV and Capital Projects to ensure changes are appropriately assessed and all required actions are identified and implemented.
  • Review and approval of process and equipment validation/qualification protocols/reports.
  • Review and approval of master batch records on MES.
  • Write, review and approve SOPs, Work Instructions, Quality Technical Agreements, Specifications, Quality Risk Assessments, PDD, PCRA and other GMP documentation in accordance with our client’s Policies.
  • Conduct Periodic Review of QA SOPs.
  • Review and approval of Supplier Change Notifications.
  • Assist with preparation of Annual Product Review documents (APRs) and YBPRs (Yearly Biological Product Reports).
  • Support cross-training of team members.
  • Support quality systems on site.
  • Support site inspection readiness activities and provide assist with audits and regulatory inspections, as required.
  • Support and drive Continuous Improvement/Lean initiatives on site.
  • Compile and present metrics as required.
  • Other duties as assigned.

Qualifications & Experience:

  • Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences, pharmacy) is required.
  • Minimum 3-5 years relevant experience in a cGMP regulated manufacturing environment, with exhibited knowledge and proficiency in Quality Assurance and Regulatory Compliance.
  • Demonstrated experience in supporting manufacturing operations, batch record review, MES and deviation/CAPA is highly desirable.
  • Experience with batch release activities is an advantage.
  • Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations.
  • Ability to coach junior QA staff.
  • Strong ability to communicate, make decisions, present data, and defend approaches in front of audiences and inspectors.
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
  • Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.